Kornimate/medical-research-clean huggingface dataset:
protopic ointment in children atopic eczema

Conditions: Dermatitis, Atopic

Summary: children with atopic eczema and a poor response to topical corticosteroid applied either protopic or fluticasone ointment twice a day for 3 weeks. they could continue during 3 more weeks once a day if needed.

treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. in the event of a flare-up the treatment was to be resumed twice a day until the end of the study. statistical methods: an interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

Eligibility criteria:
inclusion criteria: * children with moderate to severe atopic dermatitis (rajka \& langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies * female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study * informed consent * therapeutic washout for atopic dermatitis treatments exclusion criteria: * genetic epidermal barrier defect, such as netherton's syndrome, or suffering from erythroderma * any female patients who were pregnant or breast-feeding * clinical infection due to the vzv virus (varicella, zona), hsv1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum * superinfected eczema * known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment * known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation * ulcerated lesions, of whatever type * moderate to severe acne or rosacea * patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study * substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up * known serologically proven hiv positivity

Keywords: dermatitis, atopic dermatologic agents topical drug administration tacrolimus calcineurin corticosteroid fluticasone propionate child
brief, high-dose rtms for depression

Conditions: Depression; Anxiety

Summary: high frequency repetitive transcranial magnetic stimulation (rtms) has been shown to be safe, feasible, and acceptable. conventionally, rtms investigations have relied on rational decision trees for dosage determination. the purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (itbs). study 1 aims to provide a quantifiable dose-response curve for itbs and depressive symptom reduction in major depression. study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.


Eligibility criteria:
inclusion criteria: * a negative urine pregnancy test, if female subject of childbearing potential. * able to speak english and complete study forms, adhere to treatment regimens, and be willing to return for regular visits. * after full explanation of the study, willingness of participant is demonstrated by signing the informed consent form. exclusion criteria: * clinically unstable medical disease: * cardiovascular * renal * gastrointestinal * pulmonary * metabolic * endocrine * other * cns disease deemed progressive * moderate or severe traumatic brain injury (tbi) * pregnant females or those currently breast-feeding. * current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (nos) when the presence of sensory hallucinations is clearly related to the subject's trauma, bipolar type i disorder, or dementia: * vascular * alzheimer's disease * other types * repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted. see further explanation under protection from risk. * active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial * participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation. * currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. these include: * high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. stable means the same dose for 5 half-lives. * an implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant). * history of seizures or a seizure disorder.
mri screening of placenta adhesion abnormalities

Conditions: Placenta; Implantation

Summary: placenta adhesion abnormalities (paa) are the consequence of an excessive invasion of the placenta within the myometrium. paa are related to severe maternal pregnancy outcomes, especially in case of incidental discovery during delivery that increase the risk of intraoperative massive bleeding, hysterectomy and even maternal death. ultrasound is the standard modality for diagnosing paa, but magnetic resonance imaging (mri) has been increasingly performed in the case of inconclusive sonographic findings. however, standard morphological mri sequences appear as insufficient to improve the sensitivity and specificity values for detecting paa, while quantitative mri may be more efficient. the main objective of this study is to characterize the diagnostic performance of quantitative mri parameters (mainly apparent diffusion coefficient, t2 and t2\*) reflecting placental perfusion and/or oxygenation at high field, without injection of gadolinium-based agent, for the detection of paa in women with ongoing pregnancy between 30 and 38 weeks of gestation with risk factors for ppa.


Eligibility criteria:
inclusion criteria: * pregnant participant between 30 and 38 weeks of gestation, * age ≥18 years old, * participant who completed the preliminary medical examination, * participant who has received full information about the organization of the research and has signed her informed consent. * participant planning to give birth at chru of nancy * participant presenting risk factors for paa : low-lying or covering placenta or in front of the uterine scar. exclusion criteria: * multiple pregnancy, * participant presenting at least one contraindication or restriction to performing an mri as described in the protocol, in accordance with the current recommendations, * participant unable to understand or follow study procedure, * person referred to in articles l. 1121-6 to l. 1121-8, l1122-2 and l. 1122-1-2 of the public health code.
ppos (progestin primed ovarian stimulation) and corifollitropin alfa (cfa) cross-over study

Conditions: Ovarian Stimulation; Quality of Life; Preimplantation Genetic Testing; Fertility Preservation

Summary: p-ccross is a randomized, prospective monocentric phase 4 study with a crossover study design. the aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with ivf treatment with cfa (corifollitropin alfa) and ppos (progestin-primed ovarian stimulation) versus conventional ivf treatment with a recombinant fsh/gnrh antagonist. the study will also compare patients undergoing elective fertility preservation versus pgt-a (pre-implantation genetic testing for aneuploidy) patients.the study will have a crossover design so that patients will receive both forms of treatment. the investigators will also compare the endocrine profile and ovarian response of cfa/ppos versus rfsh/gnrh ovarian stimulation cycles.


Eligibility criteria:
inclusion criteria: * first ovarian stimulation cycle * aged ≥ 18 and \< 41 years old at the time of first opu * body mass index (bmi) ≥ 18 kg/m² and \< 32 kg/m² exclusion criteria: * contra-indication for ovarian stimulation * expected poor ovarian response (bologna criteria) * pcos patients * refusal to fill out questionnaires before, during and after treatment * simultaneous participation in another clinical study * untreated and uncontrolled thyroid dysfunction; * current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy; * pregnant or breastfeeding women. a woman is considered of childbearing potential (wocbp), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
a multiple dose study to assess the safety and tolerability of bms-963272 in obese but otherwise healthy adults

Conditions: Obese But Otherwise Healthy Participants

Summary: this study will assess the safety and tolerability of multiple doses of bms-963272 in obese but otherwise healthy participants.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ecgs, or laboratory results. * participants must have a bmi of 30 kg/m2 to 40 kg/m2 inclusive * women (not of childbearing potential) and men aged 18 to 60 years, inclusive exclusion criteria: * previous participation in the current study * inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study * inability to tolerate the oltt meal or to comply with oltt testing conditions * inability to tolerate oral medication * inability to tolerate venipuncture and/or inadequate venous access * women who are breastfeeding * medical conditions * history of lactose intolerance * any significant (in the opinion of the investigator) acute or chronic illness * type 1 or 2 diabetes * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg, or clinical laboratory determinations beyond what is consistent with the target population * previous/concomitant therapy * previous exposure to bms-963272 other protocol-defined inclusion/exclusion criteria could apply
expanded access program for axatilimab in chronic graft versus host disease (gvhd)

Conditions: Chronic Graft Vs. Host Disease

Summary: to provide axatilimab through an expanded access program for the treatment of graft-versus-host disease (gvhd) in united states to patients who are ineligible or unable to participate in any actively enrolling incyte-sponsored clinical studies for axatilimab in the treatment of gvhd.


Eligibility criteria:
inclusion criteria: * must be 6 years of age or older. * allogeneic hsct recipients with active cgvhd. * has refractory or recurrent active cgvhd despite at least 2 lines of systemic therapy. * be willing to avoid pregnancy or fathering children. * able to provide written informed consent and/or assent from the patient, parent, or guardian. exclusion criteria: * eligible to participate in any actively enrolling axatilimab clinical trial for the treatment of cgvhd. * history of acute or chronic pancreatitis. * has active symptomatic myositis. * has known hiv seropositive status. * has active, uncontrolled systemic bacterial, fungal, parasitic, or viral infection. * has active hbv or hcv. * inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic graft vs. host disease cgvhd expanded access program
effect of entecavir treatment on regression and disease outcome in hbv-induced liver fibrosis and cirrhosis patients

Conditions: Hepatitis B; Liver Cirrhosis

Summary: patients who have completed 2 years follow-up of the past national 12th five-year major project on infectious diseases will receive another 8 years treatment with entecavir (10 years in total). collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. understand the effects of long-term antiviral therapy on hbv-induced liver fibrosis/cirrhosis.

patients who have completed 2-years entecavir-based treatment in regress study will receive another 8 years of entecavir extension therapy. patients will be assessed at baseline and every six months for blood cell count, liver function test, hbv-dna, afp, prothrombin time, liver ultrasonography, and fibroscan; a third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. ct /mri and endoscopy will be performed at baseline and the 5th and 10th year of treatment.

Eligibility criteria:
inclusion criteria: - subjects who completed the 2 years of entecavir-based therapy in regress study; subjects who are willing to participate the extension study. exclusion criteria: - any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; pregnant women; subjects who could not compliance with the protocol judged by investigators; subjects who are not suitable for the study judged by investigators.
study of eg-1962 compared to standard of care oral nimodipine in adults with aneurysmal subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: this study compares eg-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: 1. ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling 2. external ventricular drain in place 3. subarachnoid hemorrhage on computed tomography (ct) scan of grade 2-4 on the modified fisher scale 4. wfns grade 2, 3, or 4 exclusion criteria: 1. major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm 2. angiographic vasospasm prior to randomization 3. evidence of a cerebral infarction with neurological deficit

Keywords: aneurysm, ruptured nimodipine subarachnoid hemorrhage
performing fractional flow reserve without anticoagulation during diagnostic catheterization

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess the safety of performing fractional flow reserve (ffr) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.

an experienced interventional cardiologist can perform ffr in a brief period of time. this procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation. performing ffr without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated. performing ffr without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.

Eligibility criteria:
inclusion criteria: * patients with moderate stenosis who underwent ffr without anticoagulation exclusion criteria: * therapeutic anticoagulation

Keywords: fractional flow reserve without anticoagulation
utility and effectiveness of polygenic risk scoring (prs) for coronary artery disease (cad)

Conditions: Coronary Artery Disease; Polygenic Risk Score; Heart Diseases; Coronary Disease; Myocardial Infarction; Cardiovascular Diseases

Summary: the goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (irs) to existing coronary artery risk tools by conducting a randomized prospective study. irs combines both an individual's coronary artery disease (cad) polygenic risk score (prs) and clinical risk factors, like cholesterol levels and age. this study will examine to what extent irs knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

this is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have ldl-c over 190mg/dl. participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a cad irs. participants will be randomized into two equal groups: one group will receive their irs result for coronary artery disease at baseline, and the other group will receive their ascvd pooled cohorts equation result at baseline and cad irs result approximately 3 years after enrollment. subject data will be collected for 5 years from the time of enrollment.

Eligibility criteria:
inclusion criteria: * ascvd risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations * no previous cad event (inclusive of myocardial infarction, diagnosis of cad, stroke) * previously genotyped as part of a research study that enables recontact of participants * receiving primary care at a participating institution. exclusion criteria: * prior diagnosis of cad: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting) * currently treated with lipid-lowering therapy, including statins, ezetimibe, pcsk9 inhibitors, inclisiran, or bempedoic acid * future use of statins contraindicated * prior diagnosis of cerebrovascular disease: inclusive of history of ischemic stroke, transient ischaemic attack (tia), carotid endarterectomy, carotid artery stenting * prior diagnosis of peripheral arterial disease: inclusive of history of claudication, revascularization (stents or bypass) * severe hypercholesterolemia (ldl-c ≥ 190 mg/dl)

Keywords: polygenic risk score integrated risk score genetics cardiovascular health coronary artery disease precision medicine
personalized intervention program: tobacco treatment for patients at risk for lung cancer (pip)

Conditions: Smoking Cessation; Biofeedback

Summary: the purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. each intervention will be compared to standard of care. the first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.

the primary aims of this study are to test the efficacy two types of smoking cessation methods (compared to standard care). the aim of the first intervention is to evaluate the efficacy of a personalized message intervention in improving tobacco quit rates above and beyond standard care smoking cessation treatment in patients at risk for lung cancer. messages will be designed specifically for patients at risk for lung cancer, personalized and presented in a gain-framed manner, taking into account demographics and smoking history. the aim of the second intervention is to evaluate the efficacy of a novel, biofeedback-based intervention that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way. the biomarkers include skin carotenoid status, spirometry, and plasma bilirubin, all of which improve with cessation. the study team will examine whether the biofeedback prevents relapse in those who quit and leads to reductions in smoking in lung nodule patients who failed to quit. additionally, this study will attempt to evaluate the impact of smoking cessation on mirna profiles in human serum, especially mirnas in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.

Eligibility criteria:
inclusion criteria: * current smoker. * 20 pack per year smoking history. * eligible for the smilow treatment program. * willing to enroll in smoking cessation program. * willing to be randomized in smoking cessation study. * english speaking. exclusion criteria: * dementia or current serious psychiatric or unstable medical illness. * pregnancy or breast feeding. * known fat malabsorption diseases that may affect skin carotenoid status.
evaluation of diagnostic criteria for creutzfeldt jakob disease

Conditions: Creutzfeldt Jakob Disease

Summary: clinicians know little about creutzfeldt jakob disease, and they are not proficient in the diagnostic criteria of creutzfeldt jakob disease, so it is easy to misdiagnose or delay the diagnosis. as a rare central nervous system disease, it is necessary, feasible and practical to evaluate the diagnostic criteria of creutzfeldt jakob disease.

to master the clinical application of the diagnosis of creutzfeldt jakob disease (ws / t 562-2017) and the problems in the implementation process; the rationality, practicability and operability of the diagnostic criteria were evaluated scientifically; reduce the misdiagnosis rate; to provide clinical basis and suggestions for further improving the diagnostic criteria. through consulting the literature of creutzfeldt jakob disease, the clinical manifestations, laboratory examination, auxiliary examination and pathological results of creutzfeldt jakob disease were analyzed and compared with the current diagnostic criteria; the clinical diagnosis and misdiagnosis of creutzfeldt jakob disease were analyzed; to train medical staff at all levels to apply the diagnostic criteria of creutzfeldt jakob disease, and to discuss the clinical cases of creutzfeldt jakob disease in many hospitals.

Eligibility criteria:
inclusion criteria: * patients with creutzfeldt jakob disease exclusion criteria: * none
a tailored and digital approach to address equity and support well-being for healthcare workers in the era of covid

Conditions: Depression, Anxiety; Satisfaction; Well-being

Summary: for this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. the intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. the investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. aim 1: conduct interviews of urm and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. aim 2: through a randomized controlled trial (rct) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of covid.


Eligibility criteria:
inclusion criteria: * 18 years of age; * interest in participating in an 18 month study and willing to complete regular surveys; * regular, daily access to a phone with texting capabilities * identify as a physician at penn medicine; exclusion criteria: * under 18 years of age; * not willing to sign informed consent document for an 18 month study; * no access to a phone with texting capabilities; * not a physician at penn medicine